国: カナダ
言語: 英語
ソース: Health Canada
FENOFIBRATE
BGP PHARMA ULC
C10AB05
FENOFIBRATE
48MG
TABLET
FENOFIBRATE 48MG
ORAL
30
Prescription
FRIBIC ACID DERIVATIVES
Active ingredient group (AIG) number: 0118895005; AHFS:
APPROVED
2015-01-15
_Lipidil EZ_ ® _ Product Monograph _ _ Page 1 of 45 _ _Date of Revision: February 17, 2021 and Control No. 243888 _ PRODUCT MONOGRAPH PR LIPIDIL EZ ® fenofibrate, NanoCrystal ® Formulation film-coated tablets (48 mg and 145 mg) Manufacturer’s Standard LIPID METABOLISM REGULATOR Submission Control No: 243888 ® Lipidil EZ: Registered Trademark BGP Product Operations GmbH; Licenced use by BGP Pharma ULC, a Mylan company. ® NanoCrystal: Registered Trademark Elan Pharma International Limited.; Licensed use by BGP Pharma ULC, Etobicoke, Ontario, M8Z 2S6 BGP Pharma ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 _ _ Date of Revision : February 17, 2021 _Lipidil EZ_ ® _ Product Monograph _ _ Page 2 of 45 _ _Date of Revision: February 17, 2021 and Control No. 243888 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 10 DRUG INTERACTIONS ................................................................................................. 15 DOSAGE AND ADMINISTRATION ............................................................................. 19 OVERDOSAGE ............................................................................................................... 20 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 20 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PA 完全なドキュメントを読む